NCT00599261

MAKE IT CLEAN, Impact of Pocket Revision on the Rate of Infection and Other Complications in Patients Requiring Pocket Manipulation for Generator Replacement and/or Lead Replacement or Revision: A Prospective Randomized Study

Impact of Pocket Revision on the Rate of Infection and Other Complications in Patients Requiring Pocket Manipulation for Generator Replacement and/or Lead Replacement or Revision: A Prospective Randomized Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 265 (estimated)
• Sponsor: Dhanunjaya Lakkireddy, MD, FACC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the effect of scar tissue removal on the rate of infection and any other complications such as bleeding in patients with an ICD or pacemaker who have the device generator or leads replaced or repositioned.

Detailed description

This is a randomized, prospective, single-blind study that evaluates the effect of removal of scar tissue during pacemaker/ICD pocket revision on infection and complications. Subjects will be randomly assigned to either removal of the scar tissue surrounding the implanted device during device replacement or to device replacement without removal of this tissue. Subjects will be followed for one year post-procedure for the occurrence of infection, bleeding/hematoma, or other complications.

Conditions

• Infection

Interventions

Type	Name	Description
PROCEDURE	ICD/pacemaker pocket revision	Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-01-23
• Last updated: 2013-01-10

Locations

1 site across 1 country: United States